, VIENNA, Austria, Jul 21 – The response to HIV/AIDS has gone a notch higher after a South African study indicated that a gel containing antiretroviral drug was found to be almost 40 percent effective in reducing a woman’s risk of becoming infected with HIV during sexual activity.
The results of the trial known as CAPRISA 004trial were announced at the ongoing International Aids Conference in Vienna after a two and a half year study.
“This is the first efficacy trial of an ARV based microbicide,” Dr Salim Abdool Karim of the Centre for the AIDS Programme of Research in South Africa (CAPRISA) told participants of the conference.
He said the CAPRISA 004 trial involved 889 women and aimed at evaluating the ability of one percent tenofovir (an ARV treatment) gel in preventing male to female HIV transmission.
“This is a great milestone for HIV prevention,” he said.
The research found a 39 percent lower HIV infection rate in women using the one percent tenofovir gel as compared to those women using a placebo gel (an inactive dummy medication designed to resemble a drug and given in the same way).
Dr Karim said the tenofovir gel was also found to be safe with no resistant virus detected in women who acquired HIV infection during the study. He said there were also no safety concerns in pregnancy and the babies born during the study showed no sign of congenital abnormalities.
There was also proof of concept that tenofovir gel could prevent HIV infection in women.
“It potentially adds a new approach to HIV prevention and is the first that can be used and controlled by women,” he said.
“It could help empower women to take control of their own risk of HIV infection,” he added of the study that was funded by the United States Agency for International Development (USAID).
He however said the only side effect that prevailed in the study was mild diarrhoea recorded in 17 percent of the women in the tenofovir gel.
“The efficacy results are statistically significant and should be celebrated. For the first time the HIV prevention research community has evidence that ARV’s topically applied to the vagina can offer protection against the virus.
The women were advised to use the gel 12 hours before sex and as soon as possible after sex not more than 12 hours and not more than two gels in a 24 hour period.
Dr Karim noted that there was also no decrease in condom use and other preventative strategies in the women who participated in the research.
Although there have been more than ten microbicide efficacy studies, CAPRISA 004 is the first clinical trial to study and demonstrate the efficacy of a next generation microbicide designed to prevent women from acquiring HIV through sex with an infected male partner.
The next generation products are based on antiretroviral drugs similar to the ones currently being used to treat HIV/AIDS and to reduce Mother to Child transmission of the virus.
However there is caution that additional research needs to be undertaken to confirm these results.
“We welcome the findings of the CAPRISA study. All new advances in HIV prevention particularly for women are exciting. We look forward to seeing these results confirmed. Once they have been shown to be safe and effective, WHO (World Health Organisation) will work with countries and partners to accelerate access to these products,” WHO Director Dr Margaret Chan said.